Medical Packaging in Developing Nations: Modern Dilemmas
Regulations and scrutiny in China, India, Mexico, and other developing countries continue to rise and complicate requirements for medical device packaging. The following are some of the modern dilemmas faced by medical device companies when working in developing nations. I would like to see thoughts on how to resolve them.
Design and development
The primary packaging (what surrounds the medical device) needs to contain, protect, and preserve the device. The design and material selection is heavily impacted by user needs and the supply chain. How a user interacts with, opens, stores, ships, and discards the packages in developing countries can be different from the process in the US and other developed countries. End users are very diverse culturally, and companies fail to create all-inclusive designs that are truly universal.
The material selection for packaging designs -- more specifically, the primary packaging -- is very important, because it directly interacts with the device. The materials commonly used in primary packaging need to be produced in controlled or clean environments and meet a prescribed level of cleanliness.
For a company manufacturing devices in developing nations, material procurement tends to become a big challenge. Suppliers that can provide compliant, high-quality raw materials to meet US or European standards are scarce. The dilemma: Should a company design less stringent or lower-quality medical packages to meet the demographics of developing countries? If not, what should be the strategy?
Labeling in medical device packaging typically comprises four parts:
- Product label
- Variable data label
- Patient record label
- Instructions for use (IFU)
The product label allows for product and company identification. Variable data includes the manufacturing date, expiration date, and lot number. The patient record label facilitates patient information retention, and IFU assists with intended use.
Label placement on boxes depends on storage shelves, which can be different in different nations. The labels and IFU should use country-specific languages and universal symbols to suit market needs. Label and IFU designs are usually created in the US by a variety of software packages and translated by independent firms; this can lead to errors. In addition, certain countries may restrict animal- or latex-based adhesives, and hindsight can lead to product recalls. Due to cultural, social, and lingual constraints, companies may fall short of the goal of designing universal labels.
Such issues lead to a question: How do you design a truly universal label?
Manufacturing of medical device packaging requires a clean or controlled room environment and a combination of manual assembly and semi-automatic packaging equipment. The clean room environment and equipment need to comply with ISO packaging standards. Such a setup and equipment are common in developed countries but may not always be available in developing countries.
Those setting up manufacturing plants in developing nations need to consider whether it is possible to produce compliant quality packaging at a balanced cost.
Supply chain and pricing
Sourcing (whether of equipment or raw materials) poses a serious issue for companies entering developing countries. Strategic alignment of suppliers and subsequent contractual benefitting has become a common practice in the US industry. The availability of packaging material and equipment and the pricing strategy have affected companies. Countries such as China are continuing to tighten their grip on pricing strategies.
Packaging material prices directly impact the overall cost of goods sold. Is it acceptable to source low-quality, high-cost packaging equipment and material locally? If not, should the company resort to shipping internationally? Where is the balance?
What do you think? Given these issues above, how do we resolve the dilemmas faced by medical device companies working in developing nations?
Abhishek Gautam, Packaging R&D Manager, ConMed